Randomized Controlled Trial of Ultrasound Guided Needle Placement Versus Nerve Stimulation for Coracoid Infraclavicular Brachial Plexus Block

This study has been completed.
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Canadian Anesthesiologists' Society
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00326261
First received: May 12, 2006
Last updated: December 17, 2008
Last verified: April 2006
  Purpose

Nerve blocks for arm and hand surgery provide many advantages for patients including excellent pain control and reduction in general anesthesia-related adverse effects. Infraclavicular block is possibly the best method for performing regional anesthesia of the arm because of the consistent anesthesia of the whole arm and low incidence of serious adverse effects. Normally the anesthetist uses nerve stimulation to identify nerves supplying the forearm and hand. Recent research has indicated that to improve success from 60% to 79% two types of muscle stimulation must be sought before injection of local anesthetic. This can be time consuming, requires a significant learning process, increases complications and leaves 21% of patients with inadequate anesthesia requiring supplementation or general anesthesia. More recently practitioners have been using ultrasound imaging to direct the needle and watch local anesthetic spread around the nerves. Preliminary reports have documented that this technique is associated with much greater success than the nerve stimulation method. However a good quality study comparing the dual-endpoint infraclavicular technique with an ultrasound-guided technique has not been performed. This randomized study aims to rectify this deficiency by determining if ultrasound-guided infraclavicular block has a significantly greater success than the current standard, dual end-endpoint nerve stimulation technique.


Condition Intervention
Patients Undergoing Hand Surgery
Procedure: Ultrasound compared to dual-endpoint nerve stimulator guided approach.
Procedure: Ultrasound

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Randomized Controlled Trial of Ultrasound Guided Needle Placement Versus Nerve Stimulation for Coracoid Infraclavicular Brachial Plexus Block

Further study details as provided by University Health Network, Toronto:

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective upper limb surgery at or below the elbow.
  • Patients aged > 18 and < 80 years.
  • ASA I-III.
  • BMI < 35.

Exclusion Criteria:

  • Inability to read, write or speak English. (This is necessary because subjects will have to follow detailed instructions to allow testing of motor and sensory function. it is not feasible to have an interpreter present in the block room during performance of these procedures).
  • Contraindication to brachial plexus block.
  • Existing neurological deficit in the area to be blocked.
  • Known loco-regional malignancy or infection.
  • Coagulopathy.
  • Allergy to local anesthetic agents.
  • Chest or shoulder deformities.
  • Severe respiratory disease.
  • Healed but dislocated clavicle fracture.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326261

Locations
Canada, Ontario
University Health Network, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
The Physicians' Services Incorporated Foundation
Canadian Anesthesiologists' Society
Investigators
Principal Investigator: Colin JL McCartney, MBChB FRCA FCARCSI FRCPC University Health Network, Toronto Western Hospital
  More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00326261     History of Changes
Other Study ID Numbers: 03-0126-AE
Study First Received: May 12, 2006
Last Updated: December 17, 2008
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on July 26, 2014